{ "FullStudy":{ "Rank":218255, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510704", "OrgStudyIdInfo":{ "OrgStudyId":"DP10006" }, "Organization":{ "OrgFullName":"Acacia Pharma Ltd", "OrgClass":"INDUSTRY" }, "BriefTitle":"Phase II Dose-ranging Study of APD421 in PONV", "OfficialTitle":"Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting" }, "StatusModule":{ "StatusVerifiedDate":"February 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 15, 2013", "ResultsFirstSubmitQCDate":"May 15, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 18, 2013", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 14, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 5, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Acacia Pharma Ltd", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or \"other\" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Postoperative Nausea and Vomiting" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"215", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Low dose APD421", "ArmGroupType":"Experimental", "ArmGroupDescription":"1mg dose level", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: APD421" ] } },{ "ArmGroupLabel":"Mid Dose APD421", "ArmGroupType":"Experimental", "ArmGroupDescription":"5mg dose level", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: APD421" ] } },{ "ArmGroupLabel":"High Dose APD421", "ArmGroupType":"Experimental", "ArmGroupDescription":"20mg dose level", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: APD421" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"APD421", "InterventionDescription":"IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose APD421", "Low dose APD421", "Mid Dose APD421" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Post-operative Nausea or Vomiting", "PrimaryOutcomeTimeFrame":"24 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion criteria\n\nMale or female patients ≥ 18 years of age\nAbility and willingness to give written informed consent\n\nPatients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either:\n\nHysterectomy (any surgical technique)\nCholecystectomy (any surgical technique)\nOther elective surgery requiring overnight admission to hospital and scheduled to last at least 1 hour from induction of anaesthesia\n\nPatients with at least 2 of the following risk factors for PONV:\n\nPast history of PONV and/or motion sickness\nHabitual non-smoking status\nFemale sex\nExpected to receive opioid analgesia post-operatively\nAmerican Society of Anesthesiologists (ASA) risk score I-III\n\nAdequate cardiac, hepatic and renal function\n\nQTc interval < 500 ms\nAlanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 5 x upper limit normal (ULN)\nBilirubin < 3 x ULN\nCreatinine < 2 x ULN\n\nAdequate haematological function\n\nHaemoglobin ≥ 9 g/dL\nWhite blood count ≥ 3.0 x 109/L\nPlatelet count ≥ 100 x 109/L\nFor females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) between the date of screening and at least 48 hours after administration of study drug.\n\nExclusion Criteria\n\nPatients undergoing outpatient/day case surgery\nPatients undergoing surgery where the patient is expected to remain ventilated for a period after surgery\nPatients undergoing intra-thoracic, transplant or central nervous system surgery\nPatients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block\nPatients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed\nPatients receiving the active ingredient of APD421 for any indication within the last 2 weeks\nPatients who are allergic to the active ingredient or any of the excipients of APD421\nPatients with a pre-existing vestibular disorder or history of dizziness\nPatients with pre-existing nausea or vomiting in the 24 hours before surgery\nPatients treated with regular anti-emetic therapy including corticosteroids\nPatients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin\nPatients being treated with levodopa\nPatients who are pregnant or breast feeding\nPatients with a history of alcohol abuse\nPatients with pre-existing, clinically significant cardiac arrhythmia\nPatients diagnosed with Parkinson's disease\nPatients who have received anti-cancer chemotherapy in the previous 4 weeks\nPatients with a history of epilepsy\nAny other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study\nPatients who have participated in a previous study within the last 28 days (French sites only: Patients who have participated in a previous study within the last 6 months, if required by national or local regulations)", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Peter Kranke, MD", "OverallOfficialAffiliation":"University Hospitals of Würzburg", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Duke University Medical Center", "LocationCity":"Durham", "LocationState":"North Carolina", "LocationZip":"27710", "LocationCountry":"United States" },{ "LocationFacility":"University Hospital", "LocationCity":"Besançon", "LocationCountry":"France" },{ "LocationFacility":"Hôpital mère enfant", "LocationCity":"Bron", "LocationZip":"69500", "LocationCountry":"France" },{ "LocationFacility":"Hôpital Huriez", "LocationCity":"Lille", "LocationCountry":"France" },{ "LocationFacility":"University Hospital", "LocationCity":"Nancy", "LocationCountry":"France" },{ "LocationFacility":"Hôpital FOCH", "LocationCity":"Paris", "LocationCountry":"France" },{ "LocationFacility":"Hautepierre Hospital", "LocationCity":"Strasbourg", "LocationZip":"67000", "LocationCountry":"France" },{ "LocationFacility":"HELIOS Klinikum Aue", "LocationCity":"Aue", "LocationCountry":"Germany" },{ "LocationFacility":"Charité - Universitätsmedizin", "LocationCity":"Berlin", "LocationCountry":"Germany" },{ "LocationFacility":"Universität Heidelberg", "LocationCity":"Heidelberg", "LocationCountry":"Germany" },{ "LocationFacility":"Klinikum Ludwigshafen", "LocationCity":"Ludwigshafen", "LocationCountry":"Germany" },{ "LocationFacility":"Philipps University", "LocationCity":"Marburg", "LocationCountry":"Germany" },{ "LocationFacility":"University Hospitals of Würzburg", "LocationCity":"Würzburg", "LocationCountry":"Germany" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"23872464", "ReferenceType":"derived", "ReferenceCitation":"Kranke P, Eberhart L, Motsch J, Chassard D, Wallenborn J, Diemunsch P, Liu N, Keh D, Bouaziz H, Bergis M, Fox G, Gan TJ. I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. Br J Anaesth. 2013 Dec;111(6):938-45. doi: 10.1093/bja/aet251. Epub 2013 Jul 19." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Single-dose IV placebo" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Low Dose APD421", "FlowGroupDescription":"Single-dose 1 mg IV APD421" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Mid Dose APD421", "FlowGroupDescription":"Single-dose 5 mg IV APD421" },{ "FlowGroupId":"FG003", "FlowGroupTitle":"High Dose APD421", "FlowGroupDescription":"Single-dose 20 mg IV APD421" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"54" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"58" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"50" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"53" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"54" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"58" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"50" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"53" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Low Dose APD421", "BaselineGroupDescription":"1mg dose level" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Mid Dose APD421", "BaselineGroupDescription":"5mg dose level" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"High Dose APD421", "BaselineGroupDescription":"20mg dose level" },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"54" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"58" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"50" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"53" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"215" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"49.1", "BaselineMeasurementSpread":"13.6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"50", "BaselineMeasurementSpread":"14.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50", "BaselineMeasurementSpread":"16.2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"50.7", "BaselineMeasurementSpread":"15.7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"49.9", "BaselineMeasurementSpread":"14.9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"53" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"48" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"49" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"197" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"18" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Post-operative Nausea or Vomiting", "OutcomeMeasurePopulationDescription":"ITT", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Low Dose APD421", "OutcomeGroupDescription":"1mg dose level" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Mid Dose APD421", "OutcomeGroupDescription":"5mg dose level" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"High Dose APD421", "OutcomeGroupDescription":"20mg dose level" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"54" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"58" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"50" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"37" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"20" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"30" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Placebo", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"54", "EventGroupOtherNumAffected":"52", "EventGroupOtherNumAtRisk":"54" },{ "EventGroupId":"EG001", "EventGroupTitle":"Low Dose APD421", "EventGroupDescription":"1mg dose level", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"58", "EventGroupOtherNumAffected":"50", "EventGroupOtherNumAtRisk":"58" },{ "EventGroupId":"EG002", "EventGroupTitle":"Mid Dose APD421", "EventGroupDescription":"5mg dose level", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"50", "EventGroupOtherNumAffected":"39", "EventGroupOtherNumAtRisk":"50" },{ "EventGroupId":"EG003", "EventGroupTitle":"High Dose APD421", "EventGroupDescription":"20mg dose level", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"53", "EventGroupOtherNumAffected":"46", "EventGroupOtherNumAtRisk":"53" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"POST PROCEDURAL HAEMATOMA", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"54" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"58" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"50" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Procedural pain", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"54" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"58" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"50" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"POST PROCEDURAL HAEMORRHAGE", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"54" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"58" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"50" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"WOUND HAEMATOMA", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"54" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"58" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"50" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Procedural Pain", "OtherEventOrganSystem":"Injury, poisoning and procedural complications", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"28", "OtherEventStatsNumAffected":"28", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"30", "OtherEventStatsNumAffected":"30", "OtherEventStatsNumAtRisk":"58" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"27", "OtherEventStatsNumAffected":"27", "OtherEventStatsNumAtRisk":"50" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"27", "OtherEventStatsNumAffected":"27", "OtherEventStatsNumAtRisk":"53" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"28", "OtherEventStatsNumAffected":"28", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"19", "OtherEventStatsNumAffected":"19", "OtherEventStatsNumAtRisk":"58" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"13", "OtherEventStatsNumAffected":"13", "OtherEventStatsNumAtRisk":"50" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"24", "OtherEventStatsNumAffected":"24", "OtherEventStatsNumAtRisk":"53" } ] } },{ "OtherEventTerm":"Vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"18", "OtherEventStatsNumAffected":"18", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"14", "OtherEventStatsNumAffected":"14", "OtherEventStatsNumAtRisk":"58" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"7", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"50" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"9", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"53" } ] } },{ "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"58" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"50" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"53" } ] } },{ "OtherEventTerm":"Flatulence", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"7", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"7", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"58" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"50" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"53" } ] } },{ "OtherEventTerm":"Pain", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"7", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"58" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"50" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"53" } ] } },{ "OtherEventTerm":"Procedural nausea", "OtherEventOrganSystem":"Injury, poisoning and procedural complications", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"58" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"50" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"53" } ] } },{ "OtherEventTerm":"Insomnia", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"58" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"50" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"53" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Dr Gabriel Fox", "PointOfContactOrganization":"Acacia Pharma Ltd", "PointOfContactEMail":"gabrielfox@acaciapharma.com" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009325", "ConditionMeshTerm":"Nausea" },{ "ConditionMeshId":"D000014839", "ConditionMeshTerm":"Vomiting" },{ "ConditionMeshId":"D000020250", "ConditionMeshTerm":"Postoperative Nausea and Vomiting" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012817", "ConditionAncestorTerm":"Signs and Symptoms, Digestive" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" },{ "ConditionAncestorId":"D000011183", "ConditionAncestorTerm":"Postoperative Complications" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10856", "ConditionBrowseLeafName":"Nausea", "ConditionBrowseLeafAsFound":"Nausea", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M16165", "ConditionBrowseLeafName":"Vomiting", "ConditionBrowseLeafAsFound":"Vomiting", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20658", "ConditionBrowseLeafName":"Postoperative Nausea and Vomiting", "ConditionBrowseLeafAsFound":"Postoperative Nausea and Vomiting", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14205", "ConditionBrowseLeafName":"Signs and Symptoms, Digestive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12648", "ConditionBrowseLeafName":"Postoperative Complications", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }